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Spots Global Cancer Trial Database for A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women

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Trial Identification

Brief Title: A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women

Official Title: New York Prevention Care Manager Project

Study ID: NCT00376909

Study Description

Brief Summary: RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates. PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

Detailed Description: OBJECTIVES: * Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women. * Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area. * Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy). * Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only). * Develop and implement the PCM intervention to help patients overcome barriers. * Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial. OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center. * Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility. * Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted. * Part 3: Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients are offered health education and follow-up services by telephone with a PCM. * Arm II: Patients receive usual care. PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for pilot study) patients will be accrued for this study.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Clinical Directors Network, Incorporated, New York, New York, United States

Contact Details

Name: Allen J. Dietrich, MD

Affiliation: Norris Cotton Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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